new england journal of medicine delta variant

New england journal of medicine delta variant trial#

Li, president, Merck Research Laboratories. The increases in COVID-19 cases, hospitalizations and deaths being reported globally are a stark reminder that new tools are urgently needed, which is why we are moving with speed and rigor to obtain authorizations and to accelerate broad global access to this investigational medicine for appropriate patients,” said Dr. “In MOVe-OUT, molnupiravir significantly reduced the risk of hospitalization and death among a diverse population of patients at risk for more severe COVID-19. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labor and Welfare. Regulatory applications are under review or are in the process of being submitted, including applications for Emergency Use Authorization (EUA) by the U.S. The European Medicines Agency (EMA) issued a positive scientific opinion for molnupiravir under Article 5.3 Regulation 726/2004, which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorization. Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19.

New england journal of medicine delta variant trial#

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19.